EN 61331-3:2014

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields

IEC 61331-3:2014 applies to protective devices such as protective clothing and eyewear for the protection of persons against X radiation up to 150 kV, during radiological examinations and interventional procedures. This standard deals with general requirements on the accompanying documents, on design and on materials used and with sizing, particular design features, minimum attenuation properties of materials, marking and standardized forms of statements of compliance with this standard. It covers protective clothing mainly for the protection of the operator, such as: - protective aprons; - thyroid collars; - protective gloves; - protective mittens; and - protective eyewear. It also covers protective devices for the protection of the patient, such as: - protective gonad aprons; - scrotum shields; - ovary shields; - shadow shields; and - protective aprons for dental use. The latter group of protective devices is intended to be used during radiological examinations to minimize the effects of irradiation on the reproductive organs particularly with regard to genetic damage. This second edition cancels and replaces the first edition of IEC 61331-3, published in 1998. It constitutes a technical revision. This second edition has been adapted to apply to the present technology. It includes a requirement to use a better method for the determination of attenuation properties over a broader and more clinically relevant range of radiation qualities appropriate to the use of the devices. It also covers three additional protective devices, thyroid collars, protective eyewear and protective aprons for dental use.

Strahlenschutz in der medizinischen Röntgendiagnostik - Teil 3: Schutzkleidung, Augenschutz und Abschirmungen für Patienten

Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical - Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection pour le patient

L'IEC 61331-3:2014 s'applique aux dispositifs de protection radiologique tels que les vêtements de protection radiologique et les lunettes de protection radiologique pour la protection des personnes contre les rayonnements X jusqu'à 150 kV, au cours des examens radiologiques et des interventions. La présente norme traite des exigences générales relatives aux documents d'accompagnement, concernant la conception et les matériaux utilisés ainsi que des dimensions, des caractéristiques de conception particulières, des propriétés d'atténuation des matériaux, du marquage et des formes normalisées de déclaration de conformité avec la présente norme. Elle couvre les vêtements de protection radiologique principalement destinés à la protection de l'operateur, tels que: - les tabliers de protection radiologique; - les cache-thyroïdes; - les gants de protection radiologique; - les moufles de protection radiologique; et - les lunettes de protection radiologique. Elle couvre aussi les dispositifs de protection radiologique pour la protection du patient, tels que: - les tabliers de protection radiologique des gonades; - les écrans de protection radiologique du scrotum; - les écrans de protection radiologique des ovaires; - les écrans de protection anti-rayonnement; et - les tabliers de protection radiologique pour usage dentaire. Le dernier groupe de dispositifs de protection radiologique est destiné à être utilisé au cours des examens radiologiques afin de réduire le plus possible les effets d'irradiation sur les organes reproducteurs, et en particulier les dommages génétiques. Cette deuxième édition annule et remplace la première édition de l'IEC 61331-3, parue en 1998. Elle constitue une révision technique. Cette deuxième édition a été adaptée pour s'appliquer à la technologie actuelle. Elle inclut une exigence pour l'utilisation d'une méthode améliorée pour la détermination des propriétés d'atténuation sur une plage plus large et avec une meilleure pertinence clinique de qualités de rayonnement appropriée à l'utilisation des appareils. Elle inclut trois dispositifs de protection radiologique supplémentaires, les cache-thyroïdes, les lunettes de protection radiologique et les tabliers de protection radiologique pour usage dentaire.

Sredstva za zaščito pred rentgenskim sevanjem pri medicinski diagnostiki - 3. del: Zaščitno oblačilo, zaščita za oči in zaščitni predpasnik za pacienta (IEC 61331-3:2014)

Ta del standarda IEC 61331 se uporablja za SREDSTVA ZA ZAŠČITO, kot so ZAŠČITNA OBLAČILA in ZAŠČITA ZA OČI za zaščito oseb pred RENTGENSKIM SEVANJEM do 150 kV, med RADIOLOŠKIMI pregledi in intervencijskimi postopki.
OPOMBA: SREDSTVA ZA ZAŠČITO sama po sebi niso namenjena zagotavljanju popolne zaščite oseb, ampak se uporabljajo za omejevanje odmerka, ki ga osebe prejmejo, kadar druge metode za zaščito pred RENTGENSKIM SEVANJEM niso zadostne ali jih ni mogoče uporabiti.
Ta standard obravnava:
– splošne zahteve za SPREMNE DOKUMENTE, zasnovo in uporabljene materiale;
– velikost, posamezne lastnosti zasnove, minimalne SLABILNE lastnosti materialov, oznake in standardizirane obrazce izjav o skladnosti s tem standardom.
Obravnava ZAŠČITNA OBLAČILA zlasti za zaščito UPRAVLJAVCA, kot so:
– ZAŠČITNI PREDPASNIKI;
– OVRATNIKI ZA ŠČITNICO;
– ZAŠČITNE ROKAVICE;
– ZAŠČITNI PALČNIKI;
– ZAŠČITA ZA OČI;
in SREDSTVA ZA ZAŠČITO za zaščito PACIENTA, kot so:
– PREDPASNIKI ZA ZAŠČITO SPOLNIH ŽLEZ;
– ŠČITI ZA MODA;
– ŠČITI ZA JAJČNIKE;
– SENČNI ŠČITI;
– ZAŠČITNI PREDPASNIKI ZA DENTALNO UPORABO.
Zadnja skupina SREDSTEV ZA ZAŠČITO je namenjena uporabi med RADIOLOŠKIMI pregledi, da se čim bolj omejijo učinki OBSEVANJA na reproduktivne organe, zlasti v zvezi s poškodbami genov.

General Information

• Status: Published
• Publication Date: 23-Oct-2014
• Withdrawal Date: 10-Jun-2017
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Oct-2014
• Completion Date: 24-Oct-2014
• Directive: 89/686/EEC - Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment
• Ref Project: SIST EN 61331-3:2014 - Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields

Relations

• Replaces: EN 61331-3:1999 - Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2014
1DGRPHãþD
SIST EN 61331-3:1999
6UHGVWYD]D]DãþLWRSUHGUHQWJHQVNLPVHYDQMHPSULPHGLFLQVNLGLDJQRVWLNLGHO
=DãþLWQRREODþLOR]DãþLWD]DRþLLQ]DãþLWQLSUHGSDVQLN]DSDFLHQWD,(&

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing,
eyewear and protective patient shields
/
Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical
- Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection pour le
patient
Ta slovenski standard je istoveten z: EN 61331-3:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
13.340.10 Varovalna obleka Protective clothing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61331-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2014
ICS  Supersedes EN 61331-3:1999
English Version
Protective devices against diagnostic medical X-radiation - Part
3: Protective clothing, eyewear and protective patient shields
(IEC 61331-3:2014)
Dispositifs de protection radiologique contre les Strahlenschutz in der medizinischen Röntgendiagnostik -
rayonnements X pour diagnostic médical - Partie 3: Teil 3: Schutzkleidung, Augenschutz und Abschirmungen
Vêtements et lunettes de protection radiologique, écrans de für Patienten
protection pour le patient (IEC 61331-3:2014)
(CEI 61331-3:2014)
This European Standard was approved by CENELEC on 2014-06-11. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61331-3:2014 E
Foreword
The text of document 62B/938/FDIS, future edition 2 of IEC 61331-3, prepared by SC 62B, "Diagnostic
imaging equipment", of IEC TC 62, "Electrical equipment in medical practice " was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN 61331-3:2014.
The following dates are fixed:
(dop) 2015-04-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-06-11
standards conflicting with the
document have to be withdrawn
This document supersedes EN 61331-3:2002.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 61331-3:2014 was approved by CENELEC as a European
Standard without any modification.

- 3 - EN 61331-3:2014
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD

applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 AMD 1 2012 Medical electrical equipment_- Part_1: - -
General requirements for basic safety and
essential performance; Amendment_1
IEC 60601-1 2005 Medical electrical equipment -- Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+EN 60601- 2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 60601-1-3 2008 Medical electrical equipment -- Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral Standard:
Radiation protection in diagnostic X-ray
equipment
+EN 60601-1- 2010
3:2008/corrigendum
Mar. 2010
+A1 2013  +A1 2013
+AC 2014
IEC 61331-1 2014 Protective devices against diagnostic EN 61331-1 2014
medical X-radiation -- Part 1: Determination
of attenuation properties of materials
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61331-3 ®
Edition 2.0 2014-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Protective devices against diagnostic medical X-radiation –

Part 3: Protective clothing, eyewear and protective patient shields

Dispositifs de protection radiologique contre les rayonnements X pour

diagnostic médical –
Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection

pour le patient
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX U
ICS 11.040.50 ISBN 978-2-8322-1564-7

– 2 – IEC 61331-3:2014 © IEC 2014
CONTENTS
FOREWORD . 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions. 8
4 General . 9
4.1 ACCOMPANYING DOCUMENTS . 9
4.2 Language of the ACCOMPANYING DOCUMENTS . 9
4.3 General requirement on marking . 9
4.4 Design . 9
4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS . 9
4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT . 10
4.5 Materials . 10
4.5.1 Materials effecting ATTENUATION . 10
4.5.2 Cleaning . 10
4.5.3 Touchable surfaces . 10
5 PROTECTIVE APRONS and THYROID COLLARS . 10
5.1 General . 10
5.2 Design . 10
5.3 Materials . 11
5.4 Dimensions . 11
5.5 Marking . 12
5.6 Statement of compliance . 12
6 PROTECTIVE GLOVES . 13
6.1 General . 13
6.2 Design . 13
6.3 Materials . 13
6.4 Dimensions . 13
6.5 Marking . 14
6.6 Statement of compliance . 15
7 PROTECTIVE MITTENS . 15
7.1 General . 15
7.2 Design . 15
7.3 Materials . 15
7.4 Dimensions . 15
7.5 Marking . 16
7.6 Statement of compliance . 16
8 PROTECTIVE GONAD APRONS . 17
8.1 General . 17
8.2 Design . 17
8.3 Materials . 17
8.4 Dimensions . 17
8.5 Marking . 17
8.6 Statement of compliance . 18

IEC 61331-3:2014 © IEC 2014 – 3–
9 SCROTUM SHIELDS . 18
9.1 General . 18
9.2 Design . 18
9.3 Materials . 19
9.4 Dimensions . 19
9.5 Marking . 19
9.6 Statement of compliance . 19
10 OVARY SHIELDS . 19
10.1 General . 19
10.2 Design . 20
10.3 Materials . 20
10.4 Dimensions . 20
10.5 Marking . 20
10.6 Statement of compliance . 20
11 SHADOW SHIELDS . 21
11.1 General . 21
11.2 Design . 21
11.3 Materials .
...